← Product Code LFL · K031523 # OLYMPUS ULTRASONIC SURGICAL SYSTEM (K031523) _Aomori Olympus Co., Ltd. · LFL · Oct 1, 2003 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K031523 ## Device Facts - **Applicant:** Aomori Olympus Co., Ltd. - **Product Code:** LFL - **Decision Date:** Oct 1, 2003 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended Use Olympus Ultrasonic Surgical System has been designed to be used with the Olympus SonoSurg Generator Set (SonoSurg-G2 Set) and an electrosurgical unit to cut and coagulate soft tissue for laparoscopic and intraabdominal procedures in general(open) surgery. It is also designed to cut and coagulate soft tissue for open and endoscopic procedures in urologic surgery. ## Device Story The Olympus Ultrasonic Surgical System is a surgical instrument set comprising a generator (SonoSurg-G2), a transducer (SonoSurg-T2H), and various surgical tips (scissors/hooks). The system converts electrical energy from the generator into mechanical ultrasonic vibration via the transducer to cut and coagulate soft tissue. It is intended for use by surgeons in operating rooms for open and endoscopic procedures. The device is used in conjunction with an electrosurgical unit. By providing precise tissue cutting and hemostasis, the system assists surgeons in managing soft tissue during urologic and general abdominal surgeries, potentially reducing operative time and blood loss. ## Clinical Evidence No clinical data provided. Substantial equivalence is based on technological characteristics and design similarities to predicate devices. ## Technological Characteristics System consists of a generator, transducer, and surgical tips. Operates by converting electrical energy to mechanical ultrasonic vibration. Complies with IEC 60601-1, IEC 60601-1-1, and IEC 60601-1-2 safety standards. No new patient-contacting materials. ## Predicate Devices - Harmonic Scalpel ([K002981](/device/K002981.md)) - Olympus SonoSurg Scissors Set T3000 ([K972114](/device/K972114.md)) - Hand piece ([K990430](/device/K990430.md)) - Olympus Transducer MAJ-336 ([K972114](/device/K972114.md)) - SonoSurg Generator Set SonoSurg-G2 Set ([K000095](/device/K000095.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K031523 1 of 2 OCT - 1 2003 ### 510(k) SUMMARY Olympus Ultrasonic Surgical System This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR, Section 807.92. #### A. General Information | 1. Applicant | Aomori Olympus Co,. Ltd. | |-----------------------------|-----------------------------------------| | | 2-248-1, Okkonoki | | | Kuroishi-shi, Aomori-ken, | | | 036-0357 Japan | | | (Registration No.: 9614641) | | 2. Submission Correspondent | Mayumi Ishii | | | Olympus Optical Co., Ltd. | | | 2951 Ishikawa-cho, Hachioji-shi, | | | Tokyo 192-8507, Japan | | | TEL: 81-426-42-2891 | | | FAX: 81-426-42-2291 | | | (Registration No.: 8010047) | | 3. Official Correspondent | Tina Steffanie-Oak | | | Senior R.A. Analyst | | | Olympus America Inc. | | | Two Corporate Center Drive, Melville, | | | NY 11747-3157 | | | TEL: 631-844-5477 | | | FAX: 631-844-5416 | | | E-mail: Tina. Steffanie-Oak@olympus.com | | | (Registration No.: 2429304) | #### B. Device Name, Common Name | 1. Device Name : | Olympus Ultrasonic Surgical System | |--------------------------|----------------------------------------------| | 2. Common/Usual Name : | Ultrasonic Surgical System | | 3. Classification Name : | Class II Instrument, Ultrasonic Surgical LFD | #### C. Predicate Devices : #K002981 Harmonic Scalpel #K972114 Olympus SonoSurg Scissors Set T3000 #K990430 Hand piece #K972114 Olympus Transducer MAJ-336 #K000095 SonoSurg Generator Set SonoSurg-G2 Set {1}------------------------------------------------ # K031523 20 #### D. Summary Description of the Device #### 1. Summarv The Olympus Ultrasonic Surgical System is composed of three sections, (1), (2), and (3). - (1) Olympus SonoSurg Scissors 5mm O.D. T3050" or "Olympus SonoSurg Long Hook 5mm O.D. T3060" or "Olympus SonoSurg Long Scissors 5mm O.D. T3070", or "Olympus SonoSurg Scissors 5mm O.D., HF Series. - (2) Olympus SonoSurg Transducer SonoSurg-T2H. - (3) Olympus SonoSurg Generator Set SonoSurg-G2 Set (SonoSurg-G2, MAJ-51). This device is intended to cut and coagulate soft tissue for open and endoscopic procedures in urologic surgery. #### 2. Design "Olympus Ultrasonic Surgical System" has been designed, manufactured and tested in compliance with Voluntary Safety Standards. It meets the requirements of IEC 60601-1, IEC60601-1-1,IEC60601-1-2. #### 3. Materials There are no new patient-contacting materials. #### E. Intended Use of the device Olympus Ultrasonic Surgical System has been designed to be used with the Olympus SonoSurg Generator Set (SonoSurg-G2 Set) and an electrosurgical unit to cut and coagulate soft tissue for laparoscopic and intraabdominal procedures in general(open) surgery. It is also designed to cut and coagulate soft tissue for open and endoscopic procedures in urologic surgery. #### F. Technological Characteristics Theory of the operation of "Olympus Ultrasonic Surgical System" is that the electrical energy employed in the "Olympus SonoSurg-G2" is changed to mechanical energy by ultrasonic vibration in the "Olympus SonoSurg Transducer SonoSurg-T2H". Therefore, this system can cut and coagulate body tissue by ultrasonic vibration. This system is the same as the Predicate Devices which include, "Olympus SonoSurg Scissors Set T3000(#K972114)", "Olympus Transducer MAJ-336 (#K972114)" and "Olympus SonSurg-G2 (#K000095)". #### G. Reason for not requiring clinical data When compared to the predicate devices, "Olympus Ultrasonic Surgical System" does not incorporate any significant changes that would effect safety or efficacy. Therefore clinical data is not necessary for its evaluation of safety. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure or a bird in flight, composed of flowing lines. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT - 1 2003 Aomori Olympus Co., Ltd. c/o Ms. Tina Steffanie-Oak Olympus America, Inc. Two Corporate Center Drive Melville, New York 11747-3157 Re: K031523 Trade/Device Name: Olympus Ultrasonic Surgical System Regulatory Class: Unclassified Product Code: LFL Dated: September 3, 2003 Received: September 4, 2003 Dear Ms. Steffanie-Oak: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ Page 2 - . Ms. Tina Steffanie-Oak This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Miriam C. Provost Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Image /page/4/Picture/0 description: The image displays the word "OLYMPUS" in a bold, sans-serif font. The letters are large and closely spaced, filling most of the frame. The text is solid black, creating a strong contrast against the white background. ## Indications for Use Statement 510(k) Number(if known): _Not assigned yet. K03523 Device Name: Qlympus Ultrasonic Surgical System Indications for Use : OLYMPUS Ultrasonic Surgical System has been designed to be used with the Olympus SonoSurg generator Set (SonoSurg-G2 Set) and an electrosurgical unit to cut and coagulate soft tissue for laparoscopic and intraabdominal procedures in general (open) surgery. It is also designed to cut and coagulate soft tissue for open and endoscopic procedures in urologic surgery. Miriam C. Provost Division of General, Restorative and Neurological Devices 510(k) Number_KO3/5 @3 (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) aaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaa Concurrence of CDRH, Office of Device Evaluation (ODE) ---- Prescription Use (Prescription 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/device/K031523](https://fda.innolitics.com/device/K031523) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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